This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.
Study Type
OBSERVATIONAL
Enrollment
402
Progression-Free Survival
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)
Overall Survival
Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death.
Time frame: From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)
Percentage of Participants With Bevacizumab Administration
Time frame: Up to 36 months
Percentage of Participants With Adverse Events (AEs)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time frame: Up to 53 months
Percentage of Participants With Activities of Daily Living (ADL)
The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent.
Time frame: Baseline, Month 6, 12, 24
Lawton Instrumental Activities of Daily Living Score (IADL)
The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people.
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Ch D Abbeville; Medecine B1
Abbeville, France
Clinique Du Docteur Calabet; Cromg
Agen, France
Ch D Agen; Medecine Interne II
Agen, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix-en-Provence, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix-en-Provence, France
Chd Castelluccio; Oncologie
Ajaccio, France
Clinique Claude Bernard; Onco Hematologie
Albi, France
Chi D Alencon; Medecine Ambulatoire
Alençon, France
Chi D Alencon; Medecine I
Alençon, France
Hopital Nord; Medecine A
Amiens, France
...and 156 more locations
Time frame: Baseline, Month 6, 12, 24
Percentage of Participants With Balducci Score
Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes.
Time frame: Baseline, Month 6, 12, 24